HPV InfectionHPVNCT06129253
Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)
An observational study of HPV Infection, run by International Vaccine Institute at 8 sites in 8 countries.
Trial summary
This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. Read more about this study
- Who is it for?
- Ages 9 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- Urine Sample Collection, Self-collected Vaginal Swab and Blood Samples
- How many people
- 29,750 participants
- Where
- 8 sitesin 8 countries
- Study dates
- 23 Nov 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study will enroll girls and women aged 9-50 years old, with equal distribution across the following age strata: 9-14, 15-20, 21-30, and 31-50 years.
Who may be able to join
- 9 to 50 years old (for urban and rural CSSs) at the time of enrollment.
- Resident in the selected community for at least the past 3 months (with the exception of pastoralists, refugees, and commercial sex workers).
- Able to understand the purpose of the study and study procedures.
- If aged 18 years or older or legally considered an emancipated minor, able and willing to provide consent to participate in the study including sample collection.
- If aged <18 years (and not considered an emancipated minor), supported in their participation by a parent or guardian who is able and willing to provide consent, and
- If aged <18 years (and not considered an emancipated minor), able and willing to provide assent to participate in the study.
Who cannot join
- Decline consent to participate any activity of the study.
- A medical condition or other reason, not directly related to HPV infection or HPV-related diseases, in the opinion of the investigator, precludes enrolment in the study.
Trial locations and contacts
8 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 8 countries
Bangladesh1 site
- Completed
Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, 1212
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Institut National pour la Recherche Biomedicale (INRB)
Kinshasa
Hugo Kavunga, +243823875153, hugokavunga@gmail.com
Hugo Kavunga
Ghana1 site
- Completed
University of Health and Allied Sciences (UHAS)
Ho, Volta Region
Nepal1 site
- Completed
Dhulikhel Hospital Kathmandu University Hospital (DHKUH)
Dhulikhel, 45200
Sierra Leone1 site
- Completed
College of Medicine and Allied Health Sciences (COMAHS)
Freetown
About this study
This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.
Read the detailed description
The study will incorporate a harmonized protocol among the 8 countries to estimate point-prevalence of high-risk HPV (HR HPV) in low socio-economic populations and, among specific sub-populations, the incidence of persistent HPV infection. Due to differences in study settings, study population, targeted age-group, and eligibility criteria, country-specific protocols will be developed to complement the multi-country master protocol. In the master protocol, general principles on study design and methodology will be described, while the country-specific protocol will elaborate in more detail on methodology in each country related to subject identification, the enrolment process, and laboratory analysis. A standardized survey questionnaire, with some minor country-specific adaptations, and laboratory assays will be implemented throughout the participating countries in order to generate comparable data.
Two separate approaches will be implemented to estimate prevalence and incidence respectively in each participating country. First, cross-sectional surveys (CSS) will be conducted in both urban and rural areas of selected countries in order to estimate the point prevalence of HPV infection in sub-Saharan Africa and South Asia. The CSS will enrol girls and women aged 9-50 years, with equal sample size from four age-strata: 9-14, 15-20, 21- 30, 31-50. For specific populations, age-strata will be modified to include 12-35 years olds considering the target population characteristics and local context. Multi-stage cluster random sampling or another applicable sampling strategy will be applied to ensure representativeness. Urine samples will be collected for HPV testing, along with data on demographics, socioeconomic status, sexual and reproductive history, attitudes towards and awareness and uptake of cervical cancer screening and HPV vaccination, and potential risk factors for HPV infection and cervical cancer. Additional data will be collected on knowledge of HPV, and attitudes, uptake and use of vaccines, using standardized questionnaires and case report forms.
Second, Longitudinal studies (LS) will estimate the incidence of persistent HPV infection in sexually active girls and young women in geographically defined communities and special populations. Depending on the country setting, the LS will enroll sexually active girls and women who are aged between 15-35 years and follow them up to 24 months. Participants will be tested every 6 months for 24 months to determine incident persistent HR HPV infection. In selected countries, urine and self-collected vaginal swabs (SCVS) will be collected at the first visit to determine the comparability of HPV genotyping results from both sample types. For all the other visits, only SCVS will be collected. Data on demographics, socioeconomic status, sexual and reproductive history, cervical screening, HPV vaccination, and other potential risk factors will be collected using standardized questionnaires.
Furthermore, the qualitative sub-studies in five selected countries (Bangladesh, Nepal, Pakistan, Sierra Leone, DR Congo) will follow and draw on findings from the CSS, focusing on girls and women of different age strata as well as community members (including boys and men) and key informants in the health care system in each study site. Qualitative study methods will vary depending on the site and CSS findings, but will include both individual in- depth interviews (IDIs) (up to ~ 30 individuals per site), key informant interviews as well as multiple focus group discussions (FGDs) with ~6-8 participants/group. Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site.
- Conditions
- HPV Infection
- Being tested
- Urine Sample Collection, Self-collected Vaginal Swab, Blood Samples
- Keywords
- HPV Positivity, HPV Infection, High Risk (HR) HPV, Cervical Cancer
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine Sample CollectionOther
When urine is collected as a sample in either CSS or LS, first flow urine samples will be collected
Self-collected Vaginal SwabOther
Self-collected Vaginal Swab will be collected by the participant under the supervision of a trained nurse or other health care worker.
Blood SamplesOther
If funding permits, a blood sample may be collected from participants in LS once during the follow-up period. If blood sample collection was not feasible during a visit, two additional attempts may be made to collect blood samples from LS participants during the subsequent follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional Survey | There are total 14 CSS groups among 8 participating countries: Bangladesh has 3 groups for CSS (urban CSS, rural CSS, displaced population CSS); Pakistan has 3 groups for CSS (urban CSS, rural CSS, commercial sex worker population CSS); Nepal has 1 nationally representative CSS; Sierra Leon has 1 rural CSS; Tanzania has 2 groups for CSS (pastoralists CSS, displaced population CSS); Ghana has 1 urban CSS; Zambia has 1 group for urban \& rural representative CSS; DR Congo has 2 groups for CSS (population representative sample for urban and rural CSS, displaced population CSS) Receives: Other: Urine Sample Collection | |
| Longitudinal Study | There are total 11 LS groups: Bangladesh has 2 LS groups (married women up to 25 years-old \& 26-35 years old); Sierra Leone has 2 LS groups (Young girls subject to child marriage/early pregnancy \& general population); Tanzania has 2 LS groups (fishing, mining/tuck stop community \& general population) Other 5 countries have 1 LS group in each country. Receives: Other: Urine Sample Collection; Other: Self-collected Vaginal Swab; Other: Blood Samples | |
| Qualitative Study | The qualitative sub-studies in five selected countries (Bangladesh, Nepal, Pakistan, Sierra Leone, DR Congo) will follow and draw on findings from the CSS, focusing on girls and women of different age strata as well as community members (including boys and men) and key informants in the health care system in each study site. Qualitative study methods will vary depending on the site and CSS findings, but will include both individual in- depth interviews (IDIs) (up to ~ 30 individuals per site), key informant interviews as well as multiple focus group discussions (FGDs) with ~6-8 participants/group. Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the prevalence (single time point detection) of HPV 16 and/or 18 infection among a representative sample of girls and women aged 9-50y in a range of settings.
HPV 16 and 18 are the most common types associated with an increased risk of cervical, anal, and other types of cancer. The incidence of HPV infection rises quickly after sexual debut and HPV infection is most common among young adults up to the age of 30, with incidence generally declining after that. The proposed age range of 9-50 years old for the CSS has been divided into four age-strata, 9-14, 15-20, 21-30, 31-50 years old, in order to understand the HPV prevalence among the age group targeted for primary series of HPV vaccine (9-14 years old), the age group targeted for multi-age cohort catch-up campaign (15-20 years old) and to gather prevalence data on older females.
Measured: Q4 2023 to Q4 2024
To estimate the incidence of ≥6-month persistent HPV 16 and/or 18 infection (defined as two sequential type-specific positives with an interval of 6 months) in selected populations over 2 years.
The age range for the LS will target the age group that is anticipated to have the highest incidence (e.g. newly sexually active girls and women) or to meet the specific research needs. The progression of HPV infection can lead to the development of premalignant lesions in the epithelial lining, ranging from low-grade (CIN 1) to high-grade (CIN 2 and 3). Persistent infection with high-risk HPV genotypes can result in premalignant and malignant lesions which typically take over 10-20 years to develop. An endpoint of 6-month persistent HPV infection has been commonly used in both epidemiological studies of HPV infection and clinical trials of HPV vaccines.
Measured: Q4 2023 to Q4 2026
Secondary outcomes (5)
To estimate the prevalence of high risk (HR) HPV infection among a representative sample of girls and women aged 9-50 years in a range of settings, and to evaluate potential risk factors for HPV infection.
This study aims to provide standard data among girls and women ages 9-50 in 8 countries, 3 in South Asia, and 5 in Sub-Saharan Africa, on the burden of HPV in a representative population sample of lower socio-economic status, as well as in particular vulnerable sub-populations of girls and women depending on the country.
Measured: Q4 2023 to Q4 2024
To estimate the incidence of ≥6-month persistent HR HPV infection in selected populations over 2 years.
Countries have been selected such that there will be representation from countries with high, medium, or low HIV incidence, high and low cervical cancer incidence, those with or without HPV screening and treatment programs, and countries that are in various stages of prophylactic HPV vaccine rollout.
Measured: Q4 2023 to Q4 2026
Descriptive statistics of the knowledge, attitudes, and beliefs regarding HPV vaccination, cervical cancer screening and treatment.
For each CSS and LS, study data will be summarized using descriptive statistics (mean, standard deviation, median, minimum, and maximum) for continuous variables, and counts and percentages for categorical variables. The denominator for each percentage will be the number of participants who were eligible for each CSS/LS unless otherwise specified.
Measured: Q1 2024 to Q4 2025
Descriptive statistics of the perceptions of gender norms and stigma, and gender-related dynamics that may influence HPV burden and/or create barriers that influence girls/women's access to and uptake of HPV prevention, screening, and treatment services
For each CSS and LS, study data will be summarized using descriptive statistics (mean, standard deviation, median, minimum, and maximum) for continuous variables, and counts and percentages for categorical variables. The denominator for each percentage will be the number of participants who were eligible for each CSS/LS unless otherwise specified.
Measured: Q1 2024 to Q4 2025
Sensitivity, specificity, Accuracy, ROC, Cohen's kappa coefficient of HPV genotyping results obtained from urine and self-collected vaginal swabs (SCVS).
In LS, participants will be tested every 6 months for 24 months to determine incident persistent HR HPV infection. In selected countries, urine and self-collected vaginal swabs (SCVS) will be collected at the first visit to determine the comparability of HPV genotyping results from both sample types. For all the other visits, only SCVS will be collected.
Measured: Q1 2024 to Q4 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start23 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 29,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Karolinska Institutet, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Alexandra Hill, Principal investigator, Associate Research ScientistDeborah Watson-Jones, Principal investigator, Professor of Clinical Epidemiology & International Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129253
- Sponsor's protocol ID
- GLOBE-HPV-01
- Acronym
- HPV
- Status last verified
- Jul 2025
- First submitted
- 17 Oct 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Along with the protocol, metadata, data dictionary, and participant-level data will be shared. Additionally, statistical analysis plan and analytical codes used for creating the analysis results for each publication will also be shared if applicable. The final participant-level dataset will encompass demographics, primary and secondary outcomes as well as all survey data. The study datasets will initially be stored and organized in a study database using the REDCap, specifically designed for the GLOBE-HPV study. Additionally, all datasets will be stored in an open access repository, ViVli.org. Data will be deidentified in accordance with the Safe Harbor method. Following the guidelines, the following variables will be replaced or removed from the data sets prior to data sharing. Study ID will be replaced with Dummy ID All elements of dates will be removed from data sets All information about geographic subdivisions smaller than a state/province will be removed from data sets
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)
- ClinicalTrials.gov ID
- NCT06129253
- Acronym / sponsor ID
- HPV / GLOBE-HPV-01
- Conditions
- HPV Infection
- Keywords
- HPV Positivity, HPV Infection, High Risk (HR) HPV, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 29,750 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Karolinska Institutet, Centers for Disease Control and Prevention
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.
Detailed description
The study will incorporate a harmonized protocol among the 8 countries to estimate point-prevalence of high-risk HPV (HR HPV) in low socio-economic populations and, among specific sub-populations, the incidence of persistent HPV infection. Due to differences in study settings, study population, targeted age-group, and eligibility criteria, country-specific protocols will be developed to complement the multi-country master protocol. In the master protocol, general principles on study design and methodology will be described, while the country-specific protocol will elaborate in more detail on methodology in each country related to subject identification, the enrolment process, and laboratory analysis. A standardized survey questionnaire, with some minor country-specific adaptations, and laboratory assays will be implemented throughout the participating countries in order to generate comparable data.
Two separate approaches will be implemented to estimate prevalence and incidence respectively in each participating country. First, cross-sectional surveys (CSS) will be conducted in both urban and rural areas of selected countries in order to estimate the point prevalence of HPV infection in sub-Saharan Africa and South Asia. The CSS will enrol girls and women aged 9-50 years, with equal sample size from four age-strata: 9-14, 15-20, 21- 30, 31-50. For specific populations, age-strata will be modified to include 12-35 years olds considering the target population characteristics and local context. Multi-stage cluster random sampling or another applicable sampling strategy will be applied to ensure representativeness. Urine samples will be collected for HPV testing, along with data on demographics, socioeconomic status, sexual and reproductive history, attitudes towards and awareness and uptake of cervical cancer screening and HPV vaccination, and potential risk factors for HPV infection and cervical cancer. Additional data will be collected on knowledge of HPV, and attitudes, uptake and use of vaccines, using standardized questionnaires and case report forms.
Second, Longitudinal studies (LS) will estimate the incidence of persistent HPV infection in sexually active girls and young women in geographically defined communities and special populations. Depending on the country setting, the LS will enroll sexually active girls and women who are aged between 15-35 years and follow them up to 24 months. Participants will be tested every 6 months for 24 months to determine incident persistent HR HPV infection. In selected countries, urine and self-collected vaginal swabs (SCVS) will be collected at the first visit to determine the comparability of HPV genotyping results from both sample types. For all the other visits, only SCVS will be collected. Data on demographics, socioeconomic status, sexual and reproductive history, cervical screening, HPV vaccination, and other potential risk factors will be collected using standardized questionnaires.
Furthermore, the qualitative sub-studies in five selected countries (Bangladesh, Nepal, Pakistan, Sierra Leone, DR Congo) will follow and draw on findings from the CSS, focusing on girls and women of different age strata as well as community members (including boys and men) and key informants in the health care system in each study site. Qualitative study methods will vary depending on the site and CSS findings, but will include both individual in- depth interviews (IDIs) (up to ~ 30 individuals per site), key informant interviews as well as multiple focus group discussions (FGDs) with ~6-8 participants/group. Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Survey | – | Other: Urine Sample CollectionThere are total 14 CSS groups among 8 participating countries: Bangladesh has 3 groups for CSS (urban CSS, rural CSS, displaced population CSS); Pakistan has 3 groups for CSS (urban CSS, rural CSS, commercial sex worker population CSS); Nepal has 1 nationally representative CSS; Sierra Leon has 1 rural CSS; Tanzania has 2 groups for CSS (pastoralists CSS, displaced population CSS); Ghana has 1 urban CSS; Zambia has 1 group for urban \& rural representative CSS; DR Congo has 2 groups for CSS (population representative sample for urban and rural CSS, displaced population CSS) |
| Longitudinal Study | – | Other: Urine Sample Collection, Other: Self-collected Vaginal Swab, Other: Blood SamplesThere are total 11 LS groups: Bangladesh has 2 LS groups (married women up to 25 years-old \& 26-35 years old); Sierra Leone has 2 LS groups (Young girls subject to child marriage/early pregnancy \& general population); Tanzania has 2 LS groups (fishing, mining/tuck stop community \& general population) Other 5 countries have 1 LS group in each country. |
| Qualitative Study | – | –The qualitative sub-studies in five selected countries (Bangladesh, Nepal, Pakistan, Sierra Leone, DR Congo) will follow and draw on findings from the CSS, focusing on girls and women of different age strata as well as community members (including boys and men) and key informants in the health care system in each study site. Qualitative study methods will vary depending on the site and CSS findings, but will include both individual in- depth interviews (IDIs) (up to ~ 30 individuals per site), key informant interviews as well as multiple focus group discussions (FGDs) with ~6-8 participants/group. Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site. |
Who may qualify
- Ages
- 9 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will enroll girls and women aged 9-50 years old, with equal distribution across the following age strata: 9-14, 15-20, 21-30, and 31-50 years.
Key inclusion criteria (6 listed)
- 9 to 50 years old (for urban and rural CSSs) at the time of enrollment.
- Resident in the selected community for at least the past 3 months (with the exception of pastoralists, refugees, and commercial sex workers).
- Able to understand the purpose of the study and study procedures.
- If aged 18 years or older or legally considered an emancipated minor, able and willing to provide consent to participate in the study including sample collection.
- If aged <18 years (and not considered an emancipated minor), supported in their participation by a parent or guardian who is able and willing to provide consent, and
Key exclusion criteria (2 listed)
- Decline consent to participate any activity of the study.
- A medical condition or other reason, not directly related to HPV infection or HPV-related diseases, in the opinion of the investigator, precludes enrolment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine Sample CollectionWhen urine is collected as a sample in either CSS or LS, first flow urine samples will be collected | Other | Cross-Sectional Survey, Longitudinal Study |
| Self-collected Vaginal SwabSelf-collected Vaginal Swab will be collected by the participant under the supervision of a trained nurse or other health care worker. | Other | Longitudinal Study |
| Blood SamplesIf funding permits, a blood sample may be collected from participants in LS once during the follow-up period. If blood sample collection was not feasible during a visit, two additional attempts may be made to collect blood samples from LS participants during the subsequent follow-up visits. | Other | Longitudinal Study |
Primary outcome
To estimate the prevalence (single time point detection) of HPV 16 and/or 18 infection among a representative sample of girls and women aged 9-50y in a range of settings.
Time frame: Q4 2023 to Q4 2024
HPV 16 and 18 are the most common types associated with an increased risk of cervical, anal, and other types of cancer. The incidence of HPV infection rises quickly after sexual debut and HPV infection is most common among young adults up to the age of 30, with incidence generally declining after that. The proposed age range of 9-50 years old for the CSS has been divided into four age-strata, 9-14, 15-20, 21-30, 31-50 years old, in order to understand the HPV prevalence among the age group targeted for primary series of HPV vaccine (9-14 years old), the age group targeted for multi-age cohort catch-up campaign (15-20 years old) and to gather prevalence data on older females.
To estimate the incidence of ≥6-month persistent HPV 16 and/or 18 infection (defined as two sequential type-specific positives with an interval of 6 months) in selected populations over 2 years.
Time frame: Q4 2023 to Q4 2026
The age range for the LS will target the age group that is anticipated to have the highest incidence (e.g. newly sexually active girls and women) or to meet the specific research needs. The progression of HPV infection can lead to the development of premalignant lesions in the epithelial lining, ranging from low-grade (CIN 1) to high-grade (CIN 2 and 3). Persistent infection with high-risk HPV genotypes can result in premalignant and malignant lesions which typically take over 10-20 years to develop. An endpoint of 6-month persistent HPV infection has been commonly used in both epidemiological studies of HPV infection and clinical trials of HPV vaccines.
5 secondary outcomes
To estimate the prevalence of high risk (HR) HPV infection among a representative sample of girls and women aged 9-50 years in a range of settings, and to evaluate potential risk factors for HPV infection.
Time frame: Q4 2023 to Q4 2024
To estimate the incidence of ≥6-month persistent HR HPV infection in selected populations over 2 years.
Time frame: Q4 2023 to Q4 2026
Descriptive statistics of the knowledge, attitudes, and beliefs regarding HPV vaccination, cervical cancer screening and treatment.
Time frame: Q1 2024 to Q4 2025
Descriptive statistics of the perceptions of gender norms and stigma, and gender-related dynamics that may influence HPV burden and/or create barriers that influence girls/women's access to and uptake of HPV prevention, screening, and treatment services
Time frame: Q1 2024 to Q4 2025
Sensitivity, specificity, Accuracy, ROC, Cohen's kappa coefficient of HPV genotyping results obtained from urine and self-collected vaginal swabs (SCVS).
Time frame: Q1 2024 to Q4 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes. Along with the protocol, metadata, data dictionary, and participant-level data will be shared. Additionally, statistical analysis plan and analytical codes used for creating the analysis results for each publication will also be shared if applicable. The final participant-level dataset will encompass demographics, primary and secondary outcomes as well as all survey data. The study datasets will initially be stored and organized in a study database using the REDCap, specifically designed for the GLOBE-HPV study. Additionally, all datasets will be stored in an open access repository, ViVli.org. Data will be deidentified in accordance with the Safe Harbor method. Following the guidelines, the following variables will be replaced or removed from the data sets prior to data sharing. Study ID will be replaced with Dummy ID All elements of dates will be removed from data sets All information about geographic subdivisions smaller than a state/province will be removed from data sets
Related trials for HPV Infection
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Hill principal investigator
Associate Research Scientist
Deborah Watson-Jones principal investigator
Professor of Clinical Epidemiology & International Health
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection, run by International Vaccine Institute at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bangladesh, Democratic Republic of the Congo, Ghana, Nepal, Pakistan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Lynch (+8228811149, julia.lynch@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the prevalence (single time point detection) of HPV 16 and/or 18 infection among a representative sample of girls and women aged 9-50y in a range of settings. (time frame: Q4 2023 to Q4 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.